CMC Project Manager (Cmc PM)

Novavax Gaithersburg , MD 20877

Posted 1 week ago

Novavax, Inc. (Nasdaq:NVAX), is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. NanoFlu, its quadrivalent influenza nanoparticle vaccine, is currently in a pivotal Phase 3 clinical trial to address key factors that can lead to the poor effectiveness of currently approved flu vaccines. ResVax, its RSV vaccine for infants via maternal immunization, is the only vaccine to demonstrate efficacy in a Phase 3 clinical trial. Novavax recently initiated development of a vaccine program against COVID-19. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic nanoparticles addressing urgent global health needs.

We are currently preparing for process validation and licensure of a late phase seasonal influenza vaccine and beginning phase I clinical work for a vaccine against the SARS-nCoV-2 novel Coronavirus. To assist with these programs we are seeking a CMC Project Manager who is responsible for drug substance CMC-related activities across the Novavax product portfolio, including development, tech transfer, manufacturing, and supply of clinical drug substance (DS). The ideal candidate will be a highly motivated individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.

Responsibilities include, but are not limited to:

  • Overall responsibility for all downstream drug substance activities from preclinical development through commercial supply

  • Identification, selection and management of Contract Development and Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of DS in support of ongoing clinical programs

  • Delivery of robust, scalable and cost-effective manufacturing processes that meet or exceed the target clinical profile

  • In coordination with Quality Assurance, implement stage appropriate analytical methods and protocols and ensure that all CDMOs are using systems and processes in compliance with all relevant regulatory standards

  • Oversee execution of the validation of downstream DS processes as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations

  • Assisting with the writing and reviewing documents for INDs / regulatory section submissions

  • Prepare, review, or edit cGMP batch records, CMC regulatory, and Quality documents

  • Provide input on process development strategies, overseeing CDMO development through clinical and pre-commercial stages

  • Provide technical/team support and leadership for technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates e.g. media, buffers and cleaning solutions

  • Collaboration with other CMC team members to build and execute the CMC development plan

Minimum Requirements:

  • MS or BS in science or engineering, plus at least 4 years of experience in pharmaceutical CMC

  • Proven experience in collaborating in matrix teams in a technical environment

  • Strong program management and project management skills and adept at working collaboratively with cross functional teams

  • Strong interpersonal and communication skills

  • Experience in oversight of CDMOs for process development, characterization, technology transfer, and release

  • Knowledge of CMC development from pre-clinical through clinical to commercialization

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Equal Opportunity Employer/Veterans/Disabled

Novavax, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Manager/Director Regulatory Affairs CMC

Novavax

Posted 3 weeks ago

VIEW JOBS 5/6/2020 12:00:00 AM 2020-08-04T00:00 Novavax, Inc. (Nasdaq:NVAX), is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. NanoFlu, its quadrivalent influenza nanoparticle vaccine, is currently in a pivotal Phase 3 clinical trial to address key factors that can lead to the poor effectiveness of currently approved flu vaccines. ResVax, its RSV vaccine for infants via maternal immunization, is the only vaccine to demonstrate efficacy in a Phase 3 clinical trial. Novavax recently initiated development of a vaccine program against COVID-19. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic nanoparticles addressing urgent global health needs. We are seeking a highly motivated and experienced individual for a Senior Manager/Director position in Regulatory Affairs CMC. This position is located at our Gaithersburg, MD facility and will report to the Vice President of Regulatory Affairs. The position will work in close collaboration with the Vice President of Regulatory Affairs to implement and coordinate all aspects of regulatory activities as needed to support the continued development of Novavax's investigational vaccines. Responsibilities include but are not limited to: * Assist with CMC regulatory submission strategies for investigational and ultimately commercial vaccine products. * Lead key regulatory CMC activities, including planning, writing, and reviewing of documents necessary to support regulatory submissions, including INDs and BLAs, meeting requests, briefing packages, and responses to queries from regulatory agencies. * Ensure that overall project timelines support the coordination and preparation of timely submissions. * Communicate and coordinate with relevant functional groups and project team members to identify and ensure the preparation of required CMC documentation and data needed for regulatory submissions. * Act as primary regulatory CMC representative on internal project teams and for other project development activities to ensure that development activities support and comply with the relevant regulatory requirements. * Maintain up-to-date working knowledge on relevant regulatory regulations, guidance and the current regulatory environment. Provide updated information on regulatory CMC issues to project teams and other personnel. * Establish regulatory CMC processes and procedures and provide training to other departments. Minimum Requirements: * Bachelor's degree preferably in a scientific field. An advanced degree is desirable. * A minimum of 8-10 years in the biotechnology industry with at least 6 years in Regulatory Affairs CMC. * Background in vaccine development with knowledge of the vaccine development process highly desirable. * Good understanding and experience with current GMPs and regulatory expectations for investigational products and clinical trials. * Experience with CTD format and content. * Ability to work independently and within a group setting and to interact effectively with different functional departments. * Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems. Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease. Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan. Equal Opportunity Employer/Veterans/Disabled Novavax, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Novavax Gaithersburg MD

CMC Project Manager (Cmc PM)

Novavax